Reviewed: 30 Sep 2015 Next review: 2018

Information and giving consent

Before you go into a trial, a doctor, nurse or other researcher will ask for your permission. They can’t enter you into the trial if you don’t give your written consent, after you have had plenty of time to think about it.

To help you decide whether you want to take part, the researchers should tell you:

what the trial is trying to find out

what the trial will involve and what you’ll have to do.

There are guidelines for researchers that explain what information people need to help them decide whether to take part in a clinical trial. But there’s a lot of discussion about how much people really want to know, and this varies from person to person.

It’s important that you have enough information to make an informed decision. You should feel able to ask any questions that will help you to make a decision. Before you decide, you should also feel that you have been given enough time to think about the trial and what it will mean to you.

Someone from your medical team will be able to answer any questions you may have. They will go through the possible benefits and risks of joining the trial. They should also discuss any other treatments that may be appropriate in your situation. You may want to talk about it with your family or friends, and think about any practical aspects, such as extra appointments and tests.

You will be given a patient information leaflet about the trial. You can take this away and read it in your own time before you are formally invited to take part.

If you decide to take part

If you decide that you want to take part, you may be asked to give your consent verbally to the person carrying out the trial, who will write it in your notes. You’ll then be asked to sign a consent form that says that you agree to take part. Your doctor will also sign the consent form. You’ll be given a copy to keep.

If you decide not to take part

If you decide not to take part in the trial, you can tell your doctor or nurse. Your decision will be respected and you don’t have to give a reason. There will be no change in the way that the hospital staff treat you, and you’ll be offered the standard treatment for your type of cancer.

Who is responsible for your care?

Withdrawing from a trial

Remember that even if you give your consent to a trial, you can leave it at any time without giving a reason. If you’re having a new treatment as part of a trial and then leave the trial, you may not be able to continue having the new treatment. In this situation you’ll be given the appropriate standard treatment for your type of cancer.

If you are thinking of leaving a trial it’s a good idea to discuss it with your specialist or your research nurse.

Remember that you can pull out of the trial at any stage. You have to trust that it won’t compromise your care, although I do understand that concerns people.

Ben

Confidentiality

If you agree to take part in a clinical trial, your GP will only be told if you give your consent. It can sometimes help for your GP to know you’re in a trial as they’re responsible for your day-to-day health at home. If you have any queries or problems during the trial, you should talk to the specialist doctor responsible for it, or your research nurse. Your medical records concerning the trial are confidential.

Sometimes, a representative of a relevant drug company or staff from the trials office who are co-ordinating the trial may look at your records to check that all the necessary information is collected accurately. No one who looks at your notes can give information to anyone outside the healthcare team looking after you. In the same way, when the results are published you will not be named.

Blood and tumour samples

Blood and tumour samples may be taken to help make the right diagnosis. You may be asked for your permission to use some of your samples for research into cancer. If you take part in a trial, you may also give other samples, which may be frozen and stored for future use when new research techniques become available. Your name will be removed from the samples so you can’t be identified.

The research may be carried out at the hospital where you are treated, or at another one. This type of research takes a long time, and results may not be available for many years. The samples will be used to increase knowledge about the causes of cancer and its treatment, which will hopefully improve the outlook for future patients.

Thanks

We rely on a number of sources to gather evidence for our information. If you’d like further information on the sources we use, please feel free to contact us on: bookletfeedback@macmillan.org.uk

All our information is reviewed by cancer or other relevant professionals to ensure that it’s accurate and reflects the best evidence available. We thank all those people who have provided expert review for the information on this page.

Our information is also reviewed by people affected by cancer to ensure it is as relevant and accessible as possible. Thank you to all those people who reviewed what you're reading and have helped our information to develop.

You could help us too when you join our Cancer Voices Network – find out more at: http://www.macmillan.org.uk/cancervoices

We make every effort to ensure that the information we provide is accurate and up-to-date but it should not be relied upon as a substitute for specialist professional advice tailored to your situation. So far as is permitted by law, Macmillan does not accept liability in relation to the use of any information contained in this publication or third party information or websites included or referred to in it.